US20080294144A1 - Touch Sensing Catheter - Google Patents

Abstract

A touch sensing catheter having a strain sensor assembly that may resolve the magnitude and direction of a force exerted on a distal extremity of the catheter, the strain sensor assembly being substantially insensitive to bulk temperature changes. A deformable structure having a plurality of optical fibers associated therewith that are strained by the imposition of a contact force transferred thereto. The optical fibers cooperate with the deformable structure to effect variable gap interferometers, such as Fabry-Perot resonators, that vary in operative length when a force is exerted on the deformable structure. The strain sensor assembly is rendered insensitive to bulk temperature changes by matching the coefficient of thermal expansion of the deformable body with that of the optical fibers. The strain sensor assembly may also be configured to mitigate the effects of thermal gradients using various thermal isolation techniques.

Description

FIELD OF THE INVENTION
• The disclosed invention relates generally to force sensing devices capable of resolving the magnitude and direction of a force vector. More specifically, the invention relates to a force sensing tip to aid in the positioning of catheters used in humans or animals, or for serving as feedback elements in robotic surgical systems.
BACKGROUND
• For many years, exploration and treatment of various organs or vessels has been possible using catheter-based diagnostic and treatment systems. Such catheters are introduced through a vessel leading to the cavity of the organ to be explored or treated or alternatively may be introduced directly through an incision made in the wall of the organ. In this manner, the patient avoids the trauma and extended recuperation times typically associated with open surgical procedures.
• To provide effective diagnosis or therapy, it is frequently necessary to first map the zone to be treated with great precision. Such mapping may be performed, for example, when it is desired to selectively ablate current pathways within a heart to treat atrial fibrillation. Often, the mapping procedure is complicated by difficulties in locating the zone(s) to be treated due to periodic movement of the heart throughout the cardiac cycle.
• Previously-known systems for mapping the interior of a vessel or organ are described, for example, in U.S. Pat. Nos. 6,546,271 and 6,226,542. The catheters described in those patents employ electromagnetic, electrical, magnetic or acoustic sensors to map the position of a distal end of the catheter in space and then construct a three-dimensional visualization of the vessel or organ interior.
• One drawback of such previously known mapping systems is that they rely on manual feedback of the catheter and/or impedance measurements to determine when the catheter is properly positioned in the vessel or organ. Those systems do not measure contact forces with the vessel or organ wall or detect contact forces applied by the catheter against the organ or vessel wall that may modify the true wall location. Instead, previously known mapping methods are time-consuming, dependent upon the skill of the clinician, and cannot compensate for artifacts created by excessive contact forces.
• It therefore would be desirable to provide apparatus and methods for detecting and monitoring contact forces between a mapping catheter and the wall of the organ or vessel to permit faster and more accurate mapping. It also would be desirable to provide apparatus and methods that permit the process to be automated.
• Once the topography of the vessel or organ is mapped, either the same or a different catheter may be employed to effect treatment. Depending upon the specific treatment to be applied to the vessel or organ, the catheter may comprise any of a number of end effectors, such as but not limited to RF ablation electrodes, rotary or scissor action cutting heads, laser ablation system, injection or sewing needles, fluid conveyance systems, forceps, manipulators, mapping electrodes, endoscopic vision systems and therapeutic delivery systems such as genetic impregnation devices. Exemplary systems are described, for example, in U.S. Pat. Nos. 6,120,520, 6,102,926, 5,575,787, 5,409,000 and 5,423,807.
• The effectiveness of such end effectors often depends on having the end effector in contact with the tissue of the wall of the organ or vessel. Many previously-known treatment systems include expandable baskets or hooks that stabilize the distal extremity of the catheter in contact with the tissue. Such arrangements, however, may be inherently imprecise due to the motion of the organ or vessel. Moreover, the previously-known systems do not provide the ability to sense the load applied to the distal extremity of the catheter by movement of the tissue wall.
• For example, in the case of a cardiac ablation system, at one extreme the creation of a gap between the end effector of the treatment system and the tissue wall may render the treatment ineffective, and inadequately ablate the tissue zone. At the other extreme, if the end effector of the catheter contacts the tissue wall with excessive force, it may inadvertently puncture the tissue, resulting in cardiac tamponade.
• In view of the foregoing, it would be desirable to provide a catheter-based diagnostic or treatment system that permits sensing of the load applied to the distal extremity of the catheter, including periodic loads arising from movement of the organ or tissue. It further would be desirable to have a load sensing system coupled to control operation of the end effector, so that the end effector is operated, either manually or automatically, only when the contact force is detected to fall within a predetermined range.
• U.S. Pat. No. 6,695,808 proposes several solutions to measure the force vector arising from contact with the tissue surface, including mechanical, capacitive, inductive and resistive pressure sensing devices. One drawback of such devices, however, is that they are relatively complex and must be sealed to prevent blood or other liquids from disturbing the measurements. In addition, such load sensing devices may result in an increase in the insertion profile of the distal extremity of the catheter. Still further, sensors of the types described in that patent may be subject to electromagnetic interference.
• One previously-known solution for dealing with potential electromagnetic interference in the medical environment is to use light-based systems rather than electrical measurement systems. One such light-based system is described in U.S. Pat. No. 6,470,205 to Bosselman which describes a robotic system for performing surgery comprising a series of rigid links coupled by articulated joints. A plurality of Bragg gratings are disposed at the articulated joints so that the bend angle of each joint may be determined optically, for example, by measuring the change in the wavelength of light reflected by the Bragg gratings using an interferometer.
• International Publication No. WO 01/33165 to Bucholtz describes an alternative spatial orientation system wherein wavelength changes measured in a triad of optical fiber strain sensors are used to compute the spatial orientation of a catheter or other medical instrument. Although Bucholtz discloses that the strain sensors may be encased within a deformable sheath, as is also described in Bosselman, calculation of the bend angles is not described as requiring characterization of the material properties of the deformable sheath.
• Accordingly, it would be desirable to provide diagnostic and treatment apparatus, such as a catheter or guide wire, that permits sensing of loads applied to a distal extremity of the apparatus, but which do not substantially increase the insertion profile of the apparatus. It is further desirable to provide diagnostic and treatment apparatus, such as a catheter and guide wire, that permits computation of forces applied to a distal extremity of the apparatus, and which are substantially immune to electromagnetic interference.
• An article by J. Peirs et al., entitled “Design of an Optical Force Sensor for Force Feedback during Minimally Invasive Robotic Surgery,” published by Katholieke Universiteit Leuven, Belgium, describes a tri-axial force sensor for use generating force feedback systems in a robotic surgery system. The apparatus includes a plurality of optical fibers that direct light onto a mirrored surface disposed adjacent to a distal tip of the device. The intensity of the light reflected from the mirrored surface is measured and may be correlated to the force required to impose a predetermined amount of flexure to the distal tip. The article describes a flexible and compact structure that may be used to produce variations in light intensity responsive to contact forces that deform the structure.
• International Publication No. WO 2007/015139 to Leo, et al. (Leo), discloses a device and method for resolving a force vector (magnitude and direction) applied to the distal end of a catheter. Leo discloses the use of fiber optic strain elements in a catheter that maintains essentially the same profile as with catheters that do not sense touching forces and is substantially immune to electromagnetic interference.
• Temperature changes to the probe of Leo may cause the strain elements to expand or contract relative to a reference or null state and present a false indication of mechanical strain on the elements. Accordingly, Leo discloses the use of additional fiber optic strain elements that are not subject to a mechanical load to provide an indication of the effect of the bulk temperature change of the probe, such as the shift in the returned wavelength of a fiber Bragg grating. Leo also discloses the use of temperature sensors disposed in the distal end of the probe to enable compensation of deformations arising from temperature variations.
• While the catheter with fiber optic strain elements in Leo may be useful in certain medical procedures, a limitation to the temperature indication techniques disclosed above is that the sensors are influenced by a temperature at a location that is physically removed from the strain sensing elements that resolve the force vector. The temperature compensation sensors disclosed above cannot be mounted in direct contact with the fiber optic sensor because they will interfere with the operation of and/or create a random error in the strain indications. Additional limitations of certain temperature compensation techniques may include added stiffness of the sensing structure (e.g. thermocouples), an increased profile of the catheter, or an increase in the complexity of the assembly.
• The above-mentioned references also do not disclose ways to mitigate the effects of thermal gradients within the sensor tip. Thermal gradients differ from bulk temperature changes in that they produce a range of temperatures that are present simultaneously within an assembly, even when the assembly is in thermal equilibrium. Thermal gradients commonly occur in catheter assemblies that deliver energy to a target area, such as RF ablation electrodes. The end effectors in these systems may require, for example, the delivery of an irrigation fluid that is substantially cooler than the surrounding blood temperature in order to effectively cool the end effector. The catheter and force sensing assembly contained therein may therefore be in contact with both warmer and cooler components relative to the surrounding (body fluid) temperature, causing the temperature of the force sensing assembly to be non-uniform, even when the catheter is at thermal equilibrium.
• It is therefore desirable is to provide a diagnostic and treatment apparatus, such as a catheter system, that permits computation of forces applied to a distal extremity of the catheter and is substantially insensitive to the thermal environment encountered during use of the catheter, such as exposure to body fluids and the presence of room-to-body temperature gradients, delivery of energy by an end effector and other sources of thermal gradients.
SUMMARY OF THE DISCLOSURE
• Various embodiments of the invention largely counter the effects of bulk temperature change on the strain elements of a force sensor suitable for use in a low profile assembly, such as a catheter. In various embodiments, a catheter comprising a flexible elongated body includes a strain sensor assembly affixed thereto. The strain sensor assembly includes a deformable structure having a plurality of optical fibers associated therewith. The deformable structure is strained by the imposition of a contact force transferred to the strain sensor assembly. The optical fibers are disposed relative to the deformable structure to create interferometric gaps that vary in operative length resulting from longitudinal and radial deformations of the deformable structure. Changes in the operative lengths in turn produce changes to interferometric patterns that are returned by the interferometric gaps when they are interrogated by an electromagnetic source. A controller may be provided to compute a force vector responsive to the changes in the detected interferometric pattern.
• Certain embodiments also moderate the effects of temperature gradients within a sensor assembly. Furthermore, embodiments of the invention may be configured to provide substantial mechanical amplification of the strain relative to the deflected portion of the optical assembly. In various embodiments, the above is accomplished without substantial increase to the profile of standard sized catheters, such as RF ablative head catheters. The resolution of the force vector may exceed 1-gm, a significant improvement over current fiber optic based sensors which can experience bias errors exceeding 10-gm per Kelvin of temperature change. The three-dimensional directional angle may be determined to within 5 angular degrees accuracy, and in many cases to within 1 angular degree.
• In some embodiments, the strain induced on a deflectable structure is detected with fiber optic sensors that operate on an interferometeric gap principle. With so-called “gap interferometers,” an interference pattern is created between electromagnetic energy reflected from a first reflecting surface and electromagnetic energy reflected from a second reflecting surface, the second reflecting surface being separated from the first reflecting surface. Gap interferometers that operate on this principle include but are not limited to Michelson interferometers, intrinsic Fabry-Perot resonators (where the Fabry-Perot cavity is internal to a fiber optic) and extrinsic Fabry-Perot resonators (where the Fabry-Perot cavity is external to a fiber optic). The frequency of the interference pattern is a function of several parameters, including a distance or “operative length” between the first and second reflecting surfaces, which is designed to change in proportion to the strain induced within the deflectable structure in response to an external force applied thereto. Interferometric techniques utilizing laser sources can provide an indication of the change of the distance between the reflecting surfaces. Techniques utilizing white light sources may also be implemented, providing an indication of the actual gap dimension.
• Embodiments are disclosed that substantially remedy the effects of thermal expansion. The gap that defines the interferometer is maintained between a transmitting element and a reflector element, each being supported by or being integral with portions of a deflectable structure having opposed faces that generally face each other. The distance between the opposed faces of the deflectable structure is maintained by a standoff member or members. The standoff member(s) and the transmitting member may be made of materials having coefficients of thermal expansion (CTEs) that are substantially similar. Hence, as the standoff member expands or contracts with temperature change, the transmitting element will undergo generally the same expansion or contraction to maintain the gap at substantially the same dimension. In this way, the gap dimension of the interferometer is largely insensitive to bulk temperature change of the standoff and transmitting element while remaining sensitive to changes induced by deformation of the deflectable structure.
• The dimension of the interferometric gap may be maintained in other embodiments by a structure that is designed to mechanically amplify the change in the gap dimension when a force is applied or transferred to the deflectable structure. The mechanical amplification may be achieved by incorporation of a standoff member or members that control the dimension of the gap while establishing an active length that is substantially longer than the dimension of the gap. The change in the dimension of the gap is proportional to the accumulated strain across the active length of the standoff member(s) to provide the amplification.
• Still other embodiments incorporate designs that reduce potential temperature gradients within the strains sensor assembly. Such designs may utilize various gaps between portions of the deflectable sensor that represent temperature extremes within the strain sensor assembly. The combination of mitigated temperature gradients and low CTEs of the deflectable structure (e.g. 0.5- to 2.0-×10⁻⁶per Kelvin) cooperate produce changes in the gap dimension that may be undetectable or tolerably small in operation.
• In one embodiment, a deflectable structure having proximal portion and a distal portion separated by at least one standoff member defines a separation between the proximal portion and the distal portion. A plurality of transmitting elements extending from the proximal portion and partially span the separation, each of the plurality of transmitting elements including a free end to define a plurality of free ends located between the proximal portion and the distal portion. At least one reflecting element is operatively coupled with the plurality of free ends for forming a plurality of gap interferometers, such as Fabry-Perot resonators, one of the plurality of interferometers being presented between each of the plurality of free ends and the at least one reflecting element, with each of the plurality of interferometers having an operative length between the respective free end and the at least one reflecting element. The operative length is variable and responsive to deformation of the deflectable structure. The at least one standoff portion and the transmitting element may include a substantially similar coefficient of thermal expansion in a direction parallel to the operative lengths of the plurality of interferometers so that the operative length remains within a predetermined range when the deformable structure is subject to a predetermined temperature change.
• Certain embodiments may implement a configuration for amplifying the displacement of a interferometric gap fiber optic strain gage by attaching a standoff member to a deformable assembly at two locations with a span length between the locations. An optical fiber extending substantially parallel to the standoff is attached to the standoff member and includes a free end that is partially reflective. In this embodiment, a reflector faces the free end with a variable gap therebetween, with the reflector, free end and variable gap defining an interferometric gap. The variable gap is varied when the standoff is subjected to a mechanical strain.
• The various embodiments may also include a source of electromagnetic radiation operatively coupled to and transmitting electromagnetic radiation through each of the plurality of transmitting elements to form the plurality of interferometric gaps. Each of the interferometric gaps outputs a modulated waveform characteristic of the corresponding of the operative lengths. A receiver may be operatively coupled to the plurality of transmitting elements to detect the modulated waveform.
• In another embodiment, a catheter for use in a medical procedure incorporates a flexible elongate body adopted to be introduced into a patient during the medical procedure and including a strain sensing assembly proximate a deformable portion of the elongate body. The strain sensing assembly includes a proximal portion and a distal portion separated by at least one standoff member to define a separation between the proximal portion and the distal portion. A plurality of transmitting elements extend from the proximal portion and partially spans the separation. Each of the plurality of transmitting elements includes a free end to define a plurality of free ends located between the proximal portion and the distal portion. At least one reflecting element is operatively coupled with at least one of the plurality of free ends to define a plurality of gaps for interferometery (one of the plurality of gaps being presented between each of the plurality of free ends and the at least one reflecting element). Each of the plurality of gaps has an operative length between the respective free end and the at least one reflecting element, the operative length being variable and responsive to deformation of the deformable portion of the elongate body. The at least one standoff portion and the transmitting element includes a substantially similar coefficient of thermal expansion in a direction parallel to the operative lengths of the plurality of gaps so that each of the operative lengths remains within a predetermined range when the deformable portion of the elongate body is subject to a predetermined range of bulk temperature change.
• An embodiment of the invention wherein the displacement of a fiber optic strain gage is mechanically amplified is also presented. A standoff member is attached to a deformable structure at two locations with a span length between the locations. An optical transmitting element extends substantially parallel to the standoff member along the span length, the optical transmitting element being attached to the standoff member and including a free end that is partially reflective. The optical transmitting element has a coefficient of thermal expansion substantially similar to the optical transmitting element. A reflector faces the free end to define an interferometric gap therebetween, the interferometric gap having an operative length. The operative length of the interferometric gap is varied when the standoff member is subjected to a mechanical strain for operation of the interferometric gap as the fiber optic strain gauge.
• In yet another embodiment, a strain sensor assembly includes a deformable structure and a plurality of gap interferometers operably coupled with the deformable structure. Each of the plurality of gap interferometers includes a transmitting element and also has an operative length that varies when the deformable structure is subjected to an external force. The transmitting element and the deformable structure are constructed from materials having similar coefficients of thermal expansion that enables the operative length to remain within a predetermined range when the deformable structure is subject to a predetermined range of bulk temperature change.
• In another embodiment of the invention, method of making a strain sensor assembly is disclosed. The method includes selecting at least one transmitting element having a first coefficient of thermal expansion and fabricating a deformable structure including at least one standoff member, each of the at least one standoff member having a second coefficient of thermal expansion that is substantially similar to the first coefficient of thermal expansion. The method may also include attaching the transmitting element to the deformable structure to provide an active length of the strain sensor assembly.
• In yet another embodiment of the invention, a method of making a strain sensor assembly includes selecting a strain sensing element including a transmitting element coaxial with a standoff member, the transmitting element and the standoff member having a substantially similar first coefficient of thermal expansion. The method also includes fabricating a deformable structure having a second coefficient of thermal expansion that is substantially similar to the first coefficient of thermal expansion and attaching the strain sensing element to the deformable structure to provide an active length.
• In another embodiment, a force sensing catheter assembly is disclosed including a deformable structure having a first coefficient of thermal expansion and a plurality of strain sensing elements operatively coupled with the deformable structure. Each of the plurality of strain sensing elements includes a transmitting element and a reflecting element coaxial with and attached to a standoff member to form a gap having an operative length between the transmitting element and the reflecting element. The transmitting element, the reflecting element and the standoff member each have a coefficient of thermal expansion substantially similar to the first coefficient of thermal expansion.
• In still another embodiment, a device for introduction into a human or animal body is disclosed and includes a flexible elongate body adapted to traverse a body passageway, the elongate body having a distal extremity for contact with a tissue wall of a vessel or organ. A deformable body is operatively coupled with the flexible elongate body that deforms in response to a contact force generated between the distal extremity and the tissue wall of the vessel or organ. The deformable body has a first coefficient of thermal expansion. A plurality of optical fiber sensors, each responsive to the contact force, the has a second coefficient of thermal expansion substantially similar to the first coefficient of thermal expansion such that an indication of the contact force is generated by each of the optical fiber sensors when sourced with electromagnetic radiation. The indication of the contact force is relatively insensitive to temperature over an operating range of temperatures of at least 5° C.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is an enlarged cutaway view of a strain sensor assembly according to an embodiment of the invention;
• FIG. 2 is a sectional view of the strain sensor assembly ofFIG. 1;
• FIG. 3 is an expanded view of the interferometric gap ofFIGS. 1 and 4;
• FIG. 4 is an enlarged cutaway view of a strain sensor assembly according to an embodiment of the invention;
• FIG. 5 is a block diagram of a strain sensing system in an embodiment of the invention;
• FIG. 6 is an enlarged cutaway view of a strain sensor assembly according to an embodiment of the invention;
• FIG. 7 is a sectional view of the strain sensor assembly ofFIG. 6;
• FIG. 8 is an enlarged cutaway view of a strain sensor assembly according to an embodiment of the invention;
• FIG. 9 is a sectional view of the strain sensor assembly ofFIG. 8;
• FIG. 10 is an enlarged sectional view of a strain sensor assembly having a unibody structure in an embodiment of the invention;
• FIG. 11 is a perspective view of an ablation head assembly in an embodiment of the invention;
• FIG. 12 is an end view of the ablation head assembly ofFIG. 11;
• FIG. 13 is an enlarged sectional view of a first embodiment of the ablation head assembly ofFIG. 11;
• FIG. 14 is an enlarged partial sectional view of a head configuration in an embodiment of the invention;
• FIG. 15 is an enlarged sectional view of a second embodiment of the ablation head assembly ofFIG. 11;
• FIG. 16 is an enlarged sectional view of a third embodiment of the ablation head assembly ofFIG. 11;
• FIG. 17 is an enlarged sectional view of a fourth embodiment of the ablation head assembly ofFIG. 11;
• FIG. 18 is an enlarged end view of an ablation head assembly in an embodiment of the invention;
• FIG. 19 is a cross-sectional view of the ablation head assembly ofFIG. 18; and
• FIGS. 20A through 20D are expanded views of mounting arrangements of the strain sensor ofFIG. 19.
DETAILED DESCRIPTION
• Referring toFIGS. 1 through 3, astrain sensor assembly20 is depicted according to an embodiment of the invention. In this embodiment, a proximal orbase portion22 and a distal orhead portion24 are separated by a trio ofstrain sensing elements26. Eachstrain sensing element26 includes thestandoff member28, a transmittingelement30 and a reflectingelement32. Eachstandoff member28 is comprised of ahollow tube34 having aproximal end36 and adistal end38 that are disposed insockets40 formed in the proximal anddistal portions22 and24.
• In this embodiment, the transmittingelement30 of eachstrain sensing element26 includes afree end44 that extends partway into thehollow tube34. The reflectingelement32 includes ananchor end46 and afree end48 and is housed within thehollow tube34 opposite the transmittingelement30.
• The transmitting and reflectingelements38 and42 are each secured to thehollow tube36 with apotting52 and are positioned to define agap54 between the free ends44 and48. Each of thestrain sensing elements26 are characterized by an active orstrain sensing length56 that is defined by the distance between the pottings52.
• Thegap54 and the free ends44 and48 of the transmitting and reflectingelements30 and32 may cooperate to define aninterferometric gap60 having anoperative length61. Theoperative length61 is the distance that establishes the characteristics of the interference pattern reflected back from theinterferometric gap60. Accordingly, thefree end44 of the transmittingelement30 may be faced with asemi-reflecting surface62, and thefree end48 of the reflectingelement32 may be faced with a reflectingsurface64.
• An “interferometric gap” as used herein is a gap having the qualities of the cavity of an interferometer, such as found in a Michelson interferometer or a Fabry-Perot resonator. Likewise, a “gap interferometer” as used herein is an interferometer that utilizes an interferometric gap to produce an interference pattern.
• The proximal anddistal ends28 and32 may be press fit, glued or formed integrally with the respective proximal anddistal portions22 and24. Thepottings52 may be comprised of a glue, epoxy or other adhesive compatible with the application and available to the artisan.
• Referring toFIG. 4, an alternative embodiment of thestrain sensor assembly20 is depicted. In this embodiment, the proximal anddistal ends36 and38 of thestandoff members28 are attached to the proximal anddistal portions22 and24 of thestrain sensor assembly20 withpotting52. However, the transmitting and reflectingelements30 and32 are each connected to thehollow tube34 with afusion weld66. For reasons discussed in connection withFIGS. 20C and 20D, the separation between the fusion welds66 defines theactive length56 of thestrain sensing element26 in the embodiment ofFIG. 4.
• In the preceding embodiments, thehollow tube34, transmittingelement30 and reflectingelement32 may be constructed of the same material, such as quartz. The proximal anddistal portions22 and24 may also be constructed from the same material, or of a material having a similar coefficient of thermal expansion (CTE). Likewise, the potting52 may be chosen for a closely matching CTE.
• Another factor is the moisture retention or hygroscopicity of the materials that comprise thestrain sensor assembly20. Hygroscopic materials absorb moisture and may tend to grow or swell when immersed in a liquid medium. The effect on thestrain sensing elements26 differ from the effects of thermal expansion in that only those elements exposed to the liquid medium (i.e. the hollow tube34) are potentially subject to dimensional change. In this scenario, thehollow tube34, which definesactive length56, may undergo a dimensional change, whereas the transmitting and reflectingelements30 and32 contained therein and isolated from the moisture would not undergo a proportional dimensional change.
• However, certain fiber optic materials, such as quartz, are known to be substantially non-absorbent and do not undergo detectable dimensional changes of significance when exposed to moisture.
• Referring toFIG. 5, an embodiment of astrain sensing system70 is depicted in accordance with the invention. Thestrain sensing system70 may comprise anelectromagnetic source72, acoupler74, areceiver76, anoperator console77 operatively coupled with amicroprocessor78 and astorage device79. Theelectromagnetic source72 outputs a transmittedradiation80 of electromagnetic radiation that is substantially steady state in nature, such as a laser or a broadband light source. Atransmission line82 such as a fiber optic cable carries the transmittedradiation80 to thecoupler74, which directs the transmittedradiation80 through a transmitting/receiving line84 to the transmittingelement30. A portion of the transmittedradiation80 enters theinterferometric gap60 within thestrain sensing element26. The transmittingelement30 and transmitting/receiving line84 may be coupled through aconnector86 as depicted inFIG. 5.
• The transmitting/receiving line84 may be operatively coupled with theinterferometric gap60 through a flexible,elongate catheter assembly87. In one embodiment, thecatheter assembly87 comprises aproximal portion87a, amiddle portion87band adistal portion87c. Thedistal portion87cmay include anend effector88 that contains theinterferometric gap60. The catheter assembly may be of a hollow construction (i.e. having a lumen) or of a non-hollow construction (i.e. no lumen), depending on the application.
• A portion of the radiation that enters theinterferometric gap60 is returned to transmittingelement30 as a modulated waveform89 and is transmitted back through the transmitting/receiving line84 to thereceiver76. Thestrain sensing system70 may interrogate theinterferometric gap60 at an exemplary and non-limiting rate of 10-Hz. Thereceiver76 may be chosen from a variety of receiving devices available in the art, such as but not limited to that disclosed in U.S. Pat. Nos. 5,202,939 and 5,392,117 to Belleville, et al., disclosures of which are hereby incorporated by reference other than any express definitions of terms specifically defined therein. Thereceiver76 manipulates and/or converts the incoming modulated waveform89 into digital signals for processing by themicroprocessor78.
• In operation, the characteristics of the modulated waveform89 are determined in part by the dimension of thegap54. Thestrain sensor assembly20 is configured so that thegap54 will vary when thestrain sensing element26, or more specifically thestandoff member28, experiences an axial strain. A change in the axial strain will cause a proportional change in the dimension of thegap54, thereby altering the characteristic of the modulated waveform89 transmitted to thereceiver76.
• The preceding embodiments provide a mechanical amplification of the growth of thegap54 relative to the strain experienced by thestrain sensing elements26. Thegap54 is maintained by the locations where the transmitting and reflectingelements30 and32 is anchored to the standoff members28 (i.e. pottings52 or fusion welds66). Accordingly, thegap54 will be displaced by an accumulated change in theactive length56 due to axial loading (tension or compression). The construction of thestrain sensing elements26 may be such that theactive length56 is several hundred times greater than thegap54, which provides substantial amplification of thegap54 relative to its dimension.
• Where thestandoff members28, transmittingelement30 and reflectingelement32 are constructed of the same material, the preceding embodiments may also be relatively insensitive to bulk temperature changes of thestrain sensor assembly20. For the embodiments depicted inFIGS. 1 through 4, a change in the length ΔL_Sof thestandoff member28 across theactive length56 of thestrain sensing element26 is expressed by
• 
  ΔL_S=[α·L·ΔT]_S  Eqn. (1)
• where L, α and ΔT are, respectively, the CTE, length and the change in the bulk temperature, and the subscript “S” denotes thestandoff member28. Likewise, the changes in the lengths ALT and ΔL_Rof the transmitting and reflectingmembers30 and32 across theactive length56 of thestrain sensing element26 are expressed by
• 
  ΔL_T=[α·L·ΔT]_T  Eqn. (2)
• 
  ΔL_R=[α·L·ΔT]_R  Eqn. (3)
• where the subscripts “T” and “R” denote, respectively, the transmittingelement30 and the reflectingelement32. Also, as depicted inFIGS. 1 and 3, theoperative length61 of theinterferometric gap60 can be expressed in terms of the lengths L_S, L_Tand L_Ras follows:
• 
  l_G=L_S−(L_T+L_R)  Eqn. (4)
• where l_Gis theoperative length61 of theinterferometric gap60. Accordingly, the change in the length Δl_Gmay be expressed by
• 
  Δl_G=ΔL_S−(ΔL_T+ΔL_R)=[α·L·ΔT]_S−([α·L·ΔT]_T+[α·L·ΔT]_R)  Eqn. (5)
• Consider a scenario where change in the bulk temperature of thestrain sensor assembly20 is uniform, i.e. ΔT_S=ΔT_T=ΔT_R=ΔT. Consider further the scenario where the CTE of the various components are equal, i.e. α_S=α_T=α_R=α. The expression of Eqn. 5 then reduces to
• 
  Δl_G=α·ΔT·[L_S−(L_T+L_R)]=α·ΔT·l_G  Eqn. (6)
• Hence, for configurations such as depicted inFIGS. 1 through 4 that incorporatestandoff members28, transmittingelements30 and reflectingelements32 that are constructed of the same material or materials having substantially the same CTE, the accumulated change in theactive length56 may dominate the change in the dimension of thegap54 by a factor of several hundred times, making the assembly relatively insensitive to bulk temperature changes.
• Also, forstrain sensor assemblies20 that utilize materials of low hygroscopicity, the change in theactive length56 of thestrain sensing element26 may be negligible when exposed to fluids. Alternatively, some or all of the components of thestrain sensor assembly20 may be plated or coated with a material that serves as a barrier to moisture such as poly-para-xylylene (PARYLENE). Accordingly, the embodiments depicted inFIG. 1 andFIG. 4 may be made insensitive to moisture as well as bulk temperature change by proper selection of fabrication materials.
• Referring toFIGS. 6 and 7, astrain sensor assembly90 is presented as an alternative to thestrain sensor assembly20 wherein the transmitting and reflectingelements30,32 are housed within in asingle support tube92. Thesingle support tube92 replaces the multiplehollow tubes34 ofFIGS. 1 through 4 and maintains theactive length56 of thestrain sensor assembly20. The proximal anddistal end portions22 and24 are glued to the open ends of thesingle support tube92 to form an enclosure. Alternatively, thesupport tube92 may be mounted in ring-shaped grooves formed on the interior faces of the proximal anddistal end portions22,24 (not depicted).
• Referring toFIGS. 7 and 8, astrain sensor assembly94 is depicted in another embodiment of the invention wherein thestrain sensing elements94 each comprise astandoff member28 that is adjacent to rather than concentric with the transmitting and reflectingelements30 and32. Thestandoff member28 may take the form of a straight,cylindrical rod96 as depicted, or other shapes and cross sections. A thintubular membrane98 may shroud theactive length56 of thestrain sensor assembly94 to encapsulate thesensing elements26 in a common closure.
• Functionally, thetubular membrane98 acts to keep body fluid from flooding thegap54 and interfering with the operation of theinterferometric gap60. The configuration and arrangement of thetubular membrane98 may be such that it does not exert a detectable force on thestrain sensor assembly94 when subject to thermal expansion or contraction. For example, thetubular membrane98 may be of such a thin wall and of a compliant material so that it offers negligible resistance to compression, such as with a latex or rubber material. Also, thetubular membrane98 may be mounted to thestrain sensor assembly94 with an excess length to enable the assembly to grow or contract and the gasses trapped within theannular gap54 to expand or contract without exerting a tension force on the strain sensor assembly.
• Thestrain sensor assembly94 also reduces the potential deformation and attendant effect on the dimension of thegap54 that may be caused by the expansion of trapped gas in thestrain sensor elements26 used in thestrain sensor assembly20. Generally, the effects of trapped gas on a strain measurement may be secondary or insignificant, and may not warrant attention. However, there may be applications where the expansion or contraction of trapped gas within a strain sensor assembly is notable vis-à-vis the accuracy or resolution requirements of the application.
• Pneumatically, thehollow tubes34 of thesensor elements26 each represent a thin-walled cylindrical vessel with a large length-to-diameter or “aspect” ratio. The pressure of the gas entrapped within thesensor element26 will increase or decrease with temperature change, and may cause the profile of thehollow tube34 to bulge or flex outward when the gas expands or inward when the gas contracts. The expansion or contraction may also impose an axial strain on thehollow tube34.
• Unlike the effect caused by the CTE of the sensor components, there is no congruent and offsetting expansion of the transmitting and reflectingelements30 and32. Hence, the combination of flexure of the wall and the axial strain of thehollow tube34 may cause the dimension of thegap54 to change and cause thestrains sensing system70 to register a false change in the resolved force vector.
• Likewise, thestrain sensor assembly90 ofFIGS. 6 and 7 also include a volume of trapped gas that generally may cause deformation of the structure (i.e. single support tube92) that maintains thegap54. The configuration ofstrain sensor assembly90 will also generally be more rigid and less sensitive to applied forces than the configuration ofstrain sensor assembly20.
• Thestrain sensor assembly94 reduces these deleterious effects because expansion of the trapped gas does act principally on the structure that also maintains thegap54. Rather, the pressure change will act primarily on thetubular membrane98, which is not a support element. Thetubular membrane98 may be dimensioned to freely flex inward and outward, thereby greatly reducing the pressure change and the attendant axial strain imposed on therod members96. Therod members96 may be sized to provide substantially less cross-sectional area and less stiffness than thesingle support tube92 ofstrain sensor assembly90.
• Referring toFIG. 10, astrain sensor assembly100 is depicted that includes aunibody structure101 in an embodiment of the invention. In the depicted configuration, theunibody structure101 includes abase portion102 and adistal portion104 separated by astem portion106, all concentric about acentral axis108. The base anddistal portions102 and104 may be characterized by amajor radius114 and thestem portion106 by aminor radius116 to define anannular gap118 having alength120. The transmittingelements30 may be located on asensing radius117 and extend through thebase portion102 and across a majority of thelength120 to define agap124 between thefree end44 of the transmittingelement30 and an inward-facingsurface126 of thedistal portion104. Theannular gap118 surrounded a thintubular membrane122 to form a closure123.
• As in the other embodiments disclosed above, thefree end44 of the transmittingelement30 may be configured as asemi-reflecting surface62. Theinward surface126, or at least the portions immediately opposite free ends44 of the transmittingelements30, may be made highly reflective to affect a Fabry-Perot resonator130 across thegaps124. The fabrication of the Fabry-Perot resonator130 in this way eliminates the need for reflectingelements32.
• Thetubular membrane122 may be of similar construction as discussed in connection withstrain sensor assembly94 to retain the same advantages. Theunibody structure101 may be made from a material having a CTE similar to that of the transmittingelements30. Matching the CTEs of thestructural element101 and the transmittingelements30 may be accomplished by fabricating theunibody structure101 from the same material as the transmittingelements30. However, materials suitable for fiber optic applications tend to be quite stiff, as measured by the modulus of elasticity or the so-called “Young's modulus.” Quartz, for example, has a Young's modulus of approximately 70 GPa. Compare this with, for example, structural polymers having a Young's modulus typically of 1 to 10 GPa. The result is that theunibody structure101 as depicted that is fabricated from quartz is relatively stiff and will have a reduced sensitivity to applied forces relative in comparison with thestrain sensor assemblies20,90 and94.
• Alternatively, theunibody structure101 may be comprised of a material that closely matches the CTE of the transmittingelements30 but possesses less stiffness. One such material is liquid crystal polymer (LCP). The material properties of certain LCPs may be found in “DUPONT ZENITE LCP liquid crystal polymer resin,” publication K-15415, May 2006, which is hereby incorporated by reference herein other than any express definitions of terms specifically defined therein. LCPs may be fabricated for a CTE that is 5.0-×10⁻⁶per Kelvin (5.0-λ/K) or less. A range of approximately 0.5- to 2.0-μ/K is comparable with quartz. The Young's modulus, however, is on the order of 15 GPa, several factors lower than quartz.
• The extent to which the CTEs are matched may be dictated by the particular application. One application or design may not require the same degree of accuracy in the determination of strain as another, or may not require operation over a broad range of temperatures. For example, CTEs of the various components may require closer matching if thestrain sensor20 is to operate over an operating range of 40° C. than an operating range of 5° C. Also, one configuration may have a higher mechanical amplification or gain than another which may allow for more tolerance in the matching of the various CTEs. The artisan may use expressions such as detailed in Eqns. (1) through (6) above to establish a tolerable difference between the various CTEs and still provide a relatively consistent indication of contact force result over a range of temperatures.
• In operation, theunibody structure101 will generally deform or deflect more readily under a force load for the lower Young's modulus while maintaining a suitable insensitivity to bulk temperature changes because of the closely matched CTEs of the materials, as described above. An added benefit of utilizing theunibody structure101 in thestrain sensor assembly100 is the elimination of glued or bonded joints that are load bearing. Bonding joints may tend to undergo plastic deformation and/or molecular slippage at bonding interfaces when subjected to even moderate loads. Bonding materials having a substantially different CTE may also contribute to thermal expansion errors of the assembly. These characteristics may be manifested as a hysteresis or a bias error in the strain measurement. Theunibody structure101 is free of bonded joints that experience a force load in operation. It is noted that the transmittingelements30 may be bonded to thebase portion102, but these bonds do not support a structural load due to application of a force vector on thedistal portion104.
• The sensitivity of thestrain sensor assembly100 may be further controlled by the sizing of the major and stemradii114,116. The deflection at the locations of thegaps124 under a given force applied to thedistal portion104 will generally increase as thestem radius116 is decreased. The angular deflection (i.e. rotation about an axis that is orthogonal to the central axis108) of the distal portion due to an eccentric force component will tend to be amplified as the ratio of thesensing radius117 to thestem radius116 is increased.
• Referring toFIGS. 11 through 17, an end effector142 that includes astrain sensor assembly140 within anablation head assembly138 is portrayed in an embodiment of the invention. The particular end effector142 portrayed includes a radio-frequency (RF)ablator head144. Various appurtenances may be utilized in the operation of the end effector142. In the case of theRF ablator head144, such appurtenances may include anirrigation tube146 in fluid communication with theRF ablator head144 that effuses coolant throughexit passages148. A plurality of transmittingelements30 extend into thestrain sensor assembly140.
• While the following discussions are directed to theablation head assembly138, it is understood that a variety of end effectors may be utilized and still be within the scope of the invention. Depending upon the specific treatment to be applied to the vessel or organ, the catheter may comprise any of a number of end effectors, such as but not limited to RF ablation electrodes, rotary or scissor action cutting heads, laser ablation system, injection or sewing needles, fluid conveyance systems, forceps, manipulators, mapping electrodes, endoscopic vision systems and therapeutic delivery systems such as genetic impregnation devices.
• Aforce vector150 is depicted as being applied to theRF ablator head144, theforce vector150 being characterized by an orientation that presents an angle ofapplication152 between theforce vector150 and acentral axis154 of theablation head assembly138. In practice, theforce vector150 may be in reaction to the end effector142 being brought into contact with an object such as the interior wall of a vessel or organ. The central axis may define the z-axis of an x-y-z coordinate system with origin at the distal extremity tip of theRF ablator head144.
• The cross-section A-A ofFIG. 12 is depicted inFIGS. 13 through 17 for various embodiments of the invention.FIG. 13 illustrates theablation head assembly138 as having astrain sensor assembly140athat includes aunibody structure158 having a center bore160 that accommodates theirrigation tube146. Adistal portion162 of theunibody structure158 includes areflective surface164 that cooperates with the free ends44 of the transmittingelement30 to create a Fabry-Perot resonator166 across agap167. Theunibody structure158 is wrapped with athin membrane168 to maintain keep thegaps167 free of bodily fluids during operation.
• Theunibody structure158 made of a material such as LCP to match the CTE of the transmittingelements30. Theirrigation tube146 may also be made of a material that closely matches the CTE of theunibody structure158, such as the same material as theunibody structure158 or the same material as the transmittingelements30.
• An alternative arrangement for theRF ablator head144 and thedistal portion162 of theunibody structure158 is portrayed inFIG. 14. TheRF ablator head144 includes anextension portion170 for the irrigation passage. Theextension portion170 cooperates with a socket orrecess172 on thedistal portion162 to create a joint that provides flow continuity between the center bore160 and theRF ablator head144.
• In operation, acoolant176 is routed through theirrigation tube146. Thecoolant176 may have to run substantially cooler than the ambient working environment of the catheter in order adequately cool theRF ablator head144. A contraction of theirrigation tube146 may exert a compressive force on theunibody structure158 that translates into a reduction in the dimension of thegaps167, thus casing an error in the apparent strain reading. By selecting a material that closely matches the CTE of theunibody structure158, the deleterious effects of differential thermal expansion between theirrigation tube146 and theunibody structure158 may be substantially reduced.
• The alternative arrangement ofFIG. 14 also reduces the effects of differential thermal expansion. The center bore160 carries the coolant directly, thereby eliminating the need for and the potential CTE differential presented by theirrigation tube146.
• The reduction or elimination of dissimilar CTEs in material selection, however, does not necessarily preclude the elimination of thermal expansion effects. For materials that have a non-zero CTE, there can still be thermal distortion due to the presence of thermal gradients within the assembly. Perfectly matched CTEs do not prevent different components or portions of components from expanding or contracting to different dimensions due to differences in temperature.
• Consider, for example, the effect of thermal gradients on theablation head assembly138 ofFIG. 13 or14. Non-limiting examples of the operating temperatures in a given application are 40 degrees Celsius (° C.) for theRF ablator head144, 26° C. for thecoolant176 and an ambient medium or working environment temperature of 37° C. Thecoolant176 is in close thermal coupling with theirrigation tube146 and astem portion178 of theunibody structure158, causing thestem portion178 to operate at a temperature close to that of thecoolant176. In contrast, theRF ablator head144, when operating at the higher temperature, conducts heat to thedistal portion162 of theunibody structure158. Hence, in the case of an RF ablation cathode, the temperature extremes of the system are represented at theRF ablator head144 and theirrigation tube146. The resulting increased temperature of thedistal portion162 may cause it to expand and deform, particularly out at thesensing radius117 which thermally is more closely coupled to theRF ablator head144 than to thestem portion178.
• In addition, thetransmitter elements30 extend from abase portion180 of the unibody structure at thesensing radius117, which may be located closer to themajor radius114 than to thestem radius116 to increase the force sensing resolution of theablation head assembly138. In this case, thebase portion180 at the location of thesensing radius117 will be more closely thermally coupled to the ambient medium in which theablation head assembly138 is immersed. This introduces a third temperature that further contributes to thermal gradients. The transmittingelements30 are conductively coupled to this third temperature, and may experience a thermal expansion relative to thestem portion178.
• The combination of the cooler temperature of thestem portion178, the warmer temperature of thedistal portion162 and the intermittent temperature of thebase portion180 may cause a change in the dimension of thegap167 that translates to an apparent and false change in the strain. These effects are inherent to any assembly that has components with a non-zero CTE.
• Thermal gradients can be militated against by isolating the structural components that establish the dimension of thegap167 from temperature extremes. An embodiment that utilizes this principle is presented inFIG. 15. Theablation head assembly138 depicted therein utilizes a strain sensor assembly140bthat includes aproximal portion186 anddistal portion188 separated by a singletube standoff member190, with the free ends44 of the transmittingelements30 and an opposingface192 of thedistal portion188 affecting a Fabry-Perot resonator194 having agap196. The strain sensor assembly140bcombines the single support tube concept ofFIG. 6 with the reduced stem radius and the reflective face on the distal portion concepts ofFIG. 10. Anactive length198 is defined by the distance between opposing faces of the proximal anddistal portions186 and188, and is shrouded from the ambient medium with atubular membrane200. An insulativeannular gap201 is formed between thetubular membrane200 and the singletube standoff member190.
• Anirrigation tube202 may be aligned in substantial concentricity with the singletube standoff member190. Theirrigation tube190 is supported at adistal end204 within asocket206 formed on abottom face208 of theRF ablator head144. Theirrigation tube190 is held in substantial concentric alignment with the singletube standoff member190 by abellows member210 that depends from theproximal portion186. Aradial insulative gap212 is thereby defined in the form of an annulus between the exterior diameter of theirrigation tube202 and the interior diameter of the singletube standoff member190. Anaxial insulative gap214 may also be provided between thebottom face208 of theRF ablator head144 and thedistal portion188 of the strain sensor assembly140b.
• The singletube standoff member190 may be fabricated from a variety of materials, as disclosed in the discussion attendantFIG. 6. Thebellows210 may be of a complaint material that offers little resistance to axial compression or extension. The variousinsulative gaps201,212 and214 may contain any of a number of gases, including air or nitrogen, or gases known for their thermal resistance characteristics such as argon.
• In operation, theradial gap212 thermally isolates theirrigation tube202 from the strain sensor assembly140b. In practical terms, thermal coupling between theirrigation tube202 and strain sensor assembly140bis limited to conduction through thebellows member210 and conduction and convection through the gas that fills theradial gap212. Heat transfer via conduction between theirrigation tube202 and theRF ablator head144 contributes to the cooling of theRF ablator head144 and essentially does not cool the strain sensor assembly140b. Theaxial gap214 serves to thermally isolate theRF ablator head144 from thedistal portion188, so that the conduction path is limited to acollar portion216 that is formed on thedistal portion186.
• Accordingly, the components that define the gap dimension (i.e. the distal andproximal portions186 and188, the singletube standoff member190 and the transmitting elements30) are substantially thermally isolated from the extreme temperatures posed by thecoolant176 and the Joule-heatedRF ablator head144.
• Another embodiment that incorporates the principles of thermal isolation for reduction of thermal gradients, and also utilizes an end effector in the formation of an interferometric gap, is presented inFIG. 16. Theablation head assembly138 includes astrain sensor assembly140cthat includes aunibody structure222 having a collar portion224 at a distal end226 and abase portion228, theunibody structure222 being in coaxial alignment with anirrigation tube230. The transmittingmembers30 form a plurality ofFabry Perot resonators232 between the free ends44 and a recessedreflective face234 of theRF ablator head144. The recessedreflective face234 is axially offset with respect to abottom face236 of theRF ablator head144 so that the recessed reflective face is at adatum238 that is in common with adistal extremity240 of the collar portion224. Thebase portion228 may includeannular grooves242 that define aflexure244. The coaxial arrangement between thestrain sensor assembly140cand theirrigation tube230 defines anannular gap246.
• Functionally, the location of the recessedreflective face234 on thesame datum238 as thedistal extremity240 of thestrain sensor assembly140csubstantially precludes movement of the recessedreflective face234 relative to thedistal extremity240. For example, thermal expansion of theRF ablator head144 causes it to grow outward from thedatum238, but does not change the position of the recessedreflective face234 relative to thedatum238. Hence, the dimension of the Fabry Perot resonator is not affected by the differential thermal expansion between of theRF ablator head144 and theunibody structure222.
• Theflexure244 provides compliance that accommodates thermal expansion or contraction of theirrigation tube230 that reduces the strain translated to the body of theunibody structure222. Theflexure244 also reduces the conductive coupling between theirrigation tube230 and thebase portion228. Theannular gap246 provides thermal isolation between theirrigation tube230 and theunibody structure222, as well as between theirrigation tube230 and the transmittingelements30. Theunibody structure222 also encapsulates the transmittingelements30, eliminating the need for a tubular membrane.
• FIG. 17 depicts another embodiment of the present invention. Theablation head assembly138 comprises astrain sensor assembly140dhaving aunibody structure252 with adistal portion254, astem portion256 and abase portion258. In this embodiment, the base anddistal portions258 and254 are characterized by amajor radius260, and the stem portion by astem radius262 that is less than themajor radius260. The difference inradii260 and262 creates anannular gap264. The transmittingelements230 extend into theannular gap264, with the free ends44 and areflective bottom surface266 of thedistal portion254 to create a plurality of Fabry-Perot resonators268. Atubular membrane270 encapsulates theannular gap264.
• Anirrigation tube272 is concentric with thestrain sensor assembly140d. Theirrigation tube272 includes abellows portion274 that extends at least partially between theRF ablator head144 and thebase portion258 of theunibody structure252. Aradial gap276 is defined between thebellows portion274 and thestem portion256 of thestrain sensor assembly140d.
• A distinction of thestrain sensor assembly140dembodiment is thebellows portion274 of theirrigation tube272. Thebellows portion274 may be designed for substantial radial stiffness through the use of radially-oriented fibers or cords, while remaining compliant in the axial direction.
• In operation, the axial compliance mitigates against inducement of strain in theunibody structure252 as thebellows portion274 expands and contracts. Otherwise, the function of the various gaps depicted inFIG. 17 provide thermal isolation between theirrigation tube272,RF ablator head144 and theunibody structure252. Thetubular membrane270 provides relief due to thermal expansion and contraction of the gas entrapped in theannular gap264, as discussed in connection withFIG. 8.
• Referring toFIGS. 18 through 20, an embodiment of aablation head assembly300 including astrain sensor assembly302 and a radio-frequency (RF)ablator head306. Theablation head assembly300 may include numerous appurtenances for effective operation, including but not limited to anirrigation tube308, anRF cable310 and atemperature sensor312 for monitoring the temperature of theRF ablator head306.
• In this embodiment, thestrain sensor assembly302 includes aunibody structure318 having acollar portion320, astem portion322 and abase portion324. TheRF ablator head306 is secured within thecollar portion320, and includes acentral bore326 in fluid communication withexit passages328 that may provide for cooling of theRF ablator head306 both internally and by film cooling of the exterior. Athermocouple port330 may be formed in theRF ablator head306. TheRF cable310 may be routed through anaccess port332 adjacent theirrigation tube308.
• Thestrain sensor assembly302 may utilize a plurality ofstrain sensors336 that may be of a coaxial construction and may include a transmittingelement338 and a reflectingelement340, each attached to an outertubular portion342 atcontact locations344 and346. A Fabry-Perot resonator347 having anoperative length349 is defined between the free ends of the transmitting and reflectingelements338 and340. Thestrain sensors336 may be further characterized by aproximal end348 and adistal end350.
• Referring toFIG. 20A, thestrain sensors336 may be bonded directly to theunibody structure318 across a continuous length of thestrain sensor336. One bonding technique may involve the use of a solvent designed to cause the material of theunibody structure318 to melt or flow while not affecting the material of thestrain sensor336. The solvent may be applied to an area orzone351 of theunibody structure318 where thestrain sensors336 are to be mounted, and thestrain sensor336 placed thereon. Alternatively, thestrain sensors336 may be temporarily held in place on thezone351 of theunibody structure318 and the solvent applied to both. The flowing of the material in thezone351 causes a bond between theunibody structure318 and the outertubular portion342 of thestrain sensor336. The solvent may be removed by a process such as washing or evaporation to arrest the melting process. The use of the solvent may also be incorporated with separate or non-unibody structures, such as depicted inFIG. 1 through 9, to mountstandoff members28 or190.
• Referring toFIG. 20B, an embodiment of the invention wherein thestrain sensors336 are bonded to theunibody structure318 using abonding agent355 such as glue or epoxy is depicted. Thebonding agent355 may be selected for closest available CTE, or for flexibility so that the thermal growth of the adhesive film does not impose a substantial strain on thestrain sensor336. Use of a very thin film ofbonding agent355 may also mitigate the effects of differential thermal expansion.
• Referring toFIGS. 20C and 20D, an embodiment of the invention is depicted wherein eachstrain sensor336 may be mounted to theunibody structure318 at two locations: aproximal location352 near theproximal end348 and adistal location354 near thedistal end350. Thebonding agent355 is discontinuous along aspan distance356. An active length of thestrain sensor336 may be defined by aspan distance356 between the proximal anddistal locations352 and354, or by aseparation distance358 betweencontact locations344 and346, whichever is less. Accordingly, the active length for the configuration ofFIG. 20C is generally thespan distance356, whereas the active length of the configuration ofFIG. 20D is generally theseparation distance358.
• Because the contact length between thestrain sensing element336 and thebonding agent355 is limited, the CTE of thebonding agent355 may be substantially dissimilar without introducing unacceptable error to the strain measurement.
• Theunibody structure318 may be formed withgrooves360 that enable thestrain sensing elements336 to be mounted thereto without increasing the radial profile of theablation head assembly300. Eachstrain sensing element336 has a fiberoptic lead cable362 that is in communication with thestrain sensing elements336. The fiberoptic lead cables362 may be routed throughslots364 formed in thebase portion324. Thestem portion322 has aninner diameter366 that is larger than the outer diameter of theirrigation tube308, thus providing anannulus368. Theirrigation tube308 is fabricated from a thin-walled, compliant tubing material that imposes a small or negligible strain on theunibody structure318 when undergoing expansion or contraction.
• Representative and non-limiting dimensions for theablation head assembly300 include an overall length of approximately 15- to 20-mm, an outer diameter of 2.3- to 2.6-mm (7 to 8 French) and a length of thestrain sensor336 of approximately 5- to 10-mm. Theirrigation tube308 may be a thin, tubular membrane having a wall thickness on the order of 10- to 20-micrometers (μm). When implemented, an exemplary and non-limiting dimension for the clearance between theirrigation tube308 and theinner diameter366 of thestem portion322 is 200- to 300-μm. Exemplaryoperative lengths349 may range from 10- to 50-μm.
• In operation, strain that is experienced by theunibody structure318 is translated to theouter tubing portion342 of thestrain sensor336 via thebonding agents355 at the proximal anddistal locations352 and354. The strain experienced by theouter tubing portion342 causes the transmitting and reflectingelements338 and340 to translate along the central axis of thestrain sensor336, thereby altering the dimension of the Fabry-Perot resonator347. The magnitude of the translation is the same as the magnitude of the relative movement betweencontact locations344 and346. For configurations where thedistance358 betweencontact locations344 and346 is less than thespan distance356 between the proximal anddistal locations352 and354, such as depicted inFIG. 20C, only the translation betweencontact locations344 and346 is sensed by the Fabry-Perot resonator. However, for configurations where thespan distance356 is less than thedistance358, such as depicted inFIG. 20D, only the translation between the proximal anddistal locations352 and354 may be sensed because the portions of theouter tube342 located outside thespan distance356 are not strained.
• Theannulus368 separates theirrigation tube308 from thestem portion322, providing some of the thermal isolation advantages and effects previously discussed.
• A method of inferring a three-dimensional force vector (magnitude and direction) from strain and temperature measurements to a force vector having magnitude is presented in International Publication No. WO 2007/015139 to Leo, et al., the disclosure of which is hereby incorporated by reference other than any express definitions of terms specifically defined therein. A modification to the method sans temperature measurements is presented below.
• An elastic strain ε corresponding to a given change in the operative length of an interferometric gap may be determined with commercially available instruments, such as the FTI-10 Single-Channel Signal Conditioner marketed by FISO Technologies, Inc. of Quebec, Canada. Consider the strain sensor assembly ofFIG. 18, depicting the threestrain sensors336. The elastic strains ε are related to the internal forces experienced by the standoff member(s) as a function of the physical dimensions and the material properties of the deformable body.
• $\begin{array}{cc}\left[\begin{array}{c}{\varepsilon }_{\mathrm{el}1,t}\\ {\varepsilon }_{\mathrm{el}2,t}\\ {\varepsilon }_{\mathrm{el}3,t}\end{array}\right]=\left[\begin{array}{ccc}1& y_1& -x_1\\ 1& y_2& -x_2\\ 1& y_3& -x_3\end{array}\right]·\left[\begin{array}{ccc}\frac{1}{E_{\mathrm{ten}}·A}& 0& 0\\ 0& \frac{1}{E_{\mathrm{flex}}·I_x}& 0\\ 0& 0& \frac{1}{E_{\mathrm{flex}}·I_y}\end{array}\right]·\left[\begin{array}{c}{N}_{z,t}\\ M_{x,t}\\ M_{y,t}\end{array}\right]{\varepsilon }_{\mathrm{el},t}=G·\delta ·I_{F,t}& \mathrm{Eqn}.\left(7\right)\end{array}$
• • Where:
    • x_iand y_i, i=1, 3—coordinates of gap interferometer with respect to center of gravity of the catheter cross-section
    • ε_elij, i=1, 3—elastic strain values at time t
    • E_ten—Equivalent tension/compression Young modulus of catheter
    • E_flex—Equivalent flexural Young modulus of catheter
    • I_x—Moment of inertia with respect to x axis
    • I_y—Moment of inertia with respect to y axis
    • N_z,t—Normal force in direction of z axis at time t
    • M_x,t—Bending moment with respect to x axis at time t
    • M_y,t—Bending moment with respect to y axis at time t
      • G—Geometry matrix
      • δ—Matrix of flexibility
      • I_F,t—Matrix (vector) of internal forces at time t
• Equation (7) may be rearranged to solve for the internal forces as a function of the elastic strain:
• $\begin{array}{cc}\left[\begin{array}{c}{N}_{z,t}\\ M_{x,t}\\ M_{y,t}\end{array}\right]=\left[\begin{array}{ccc}{E}_{\mathrm{ten}}·A& 0& 0\\ 0& E_{\mathrm{flex}}·I_x& 0\\ 0& 0& E_{\mathrm{flex}}·I_y\end{array}\right]·{\left[\begin{array}{ccc}1& y_1& -x_1\\ 1& y_2& -x_2\\ 1& y_3& -x_3\end{array}\right]}^{1-}·\left[\begin{array}{c}{\varepsilon }_{\mathrm{el}1,t}\\ {\varepsilon }_{\mathrm{el}2,t}\\ {\varepsilon }_{\mathrm{el}3,t}\end{array}\right]I_{F,t}=S·G^{-1}·{\varepsilon }_{\mathrm{el},t}& \mathrm{Eqn}.\left(8\right)\end{array}$
• • Where: S=δ⁻¹—Stiffness matrix
• The internal forces experienced by the optical fiber sensors are computed based on the positions of the optical fiber sensors from the exterior wall of the deformable body, assuming the deformable body is substantially incompressible:
• $\begin{array}{cc}\left[\begin{array}{c}{F}_{x,t}\\ F_{y,t}\\ F_{z,t}\end{array}\right]=\left[\begin{array}{ccc}0& 0& -\frac{1}{d}\\ 0& \frac{1}{d}& 0\\ -1& 0& 0\end{array}\right]·\left[\begin{array}{c}{N}_{z,1}\\ M_{x,t}\\ M_{y,t}\end{array}\right]F_t=d·I_{F,t}& \mathrm{Eqn}.\left(9\right)\end{array}$
• • Where:
    • F_x,t—Touching external transversal force at time t, in direction of x axis (with opposite sense)
    • F_y,t—Touching external transversal force at time t, in direction of y axis (with opposite sense)
    • F_z,t—Touching external normal force at time t in direction of z axis (with opposite sense, compression is positive)
    • d—distance between the touching point of lateral forces and the cross-section with sensors (along z axis)
      • F_t—Matrix of touching external forces at time t
      • d—Matrix of conversion
• The solution of Eqns. (7) through (9) provides a normal and a transverse force applied to the external surface of the deformable body, i.e., F_norm,t=F_z,tand F_trans,t=square root (F²_x,t+F²_y,t) An angle of application γ_tof the transverse force may be computed from Table I:

• 	TABLE I
  	Fx,t	Fy,t	γt

  	≧0	≧0	arcsin(Fy,t/Ftran,t)
  	<0	≧0	Π − arcsin(Fy,t/Ftran,t)
  	<0	<0	Π + arcsin(Fy,t/Ftran,t)
  	≧0	<0	2 * Π − arcsin(Fy,t/Ftran,t)

• Equations (7) through (9) are related to the material properties of the deformable body or optical fiber sensors, such as the elastic moduli of the deformable body. Other values, such as the coordinate distances between the optical fiber sensors, the operative lengths of the interferometric gaps and the external surface of the deformable body may be subject to variations as a consequence manufacturing tolerances.
• To improve the accuracy of the computed force vector, specific information for each deformable body may be stored instorage device79. Generally, the information make take the form of a data file that is input to console77 prior to use of thestrain sensor assembly20. For example,storage device79 may comprise a memory chip associated with the transmitting/receiving line84 in which such information is stored, or a bar code or a RFID tag located on the body of thestrain sensor assembly20 or on the packaging. Alternatively, data specific to an individual deformable body may be uploaded to console77 from an item of removable storage (e.g., CD) or via secure download from the manufacturer's website.
• The information specific to each deformable body may be obtained during a calibration step, conducted during manufacture of the deformable body, by subjecting the deformable body to a series of known forces. In this case, the foregoing equations may be collapsed so the normal and transverse forces may be computed directly from a strain-to-force conversion matrix:
• 
  F(t)=K(ε(t)−ε₀)  Eqn. (11)
• where F(t) is the vector of forces [F_x,,t, F_y,,t, F_z,,t] (corresponding for example to theforce vector150 ofFIG. 11), ε (t) is the vector of strains [ε_1,t, ε_2,t, ε_3,t] of the interference pattern measured for the individual sensors, ε₀is the vector of strains [ε⁰₁, ε⁰₂, ε⁰₃] measured for the individual sensors with zero applied force, and K is a matrix computed when the deformable body is subjected to the series of known forces
• During the calibration step of manufacture, in constant temperature conditions, the deformable body is subjected to the following forces in series: (1) a purely axial force of known magnitude F_z,t; (2) a lateral force of known magnitude F_x,t; and (3) a lateral force of known magnitude F_y,tapplied 90 degrees to the orientation of force F_x,t. When all of the forces [F_x,,t, F_y,,t, F_z,,t] and wavelengths are known, the force-to-strain conversion matrix K may be computed as:
• $\begin{array}{cc}K={F\left(\varepsilon \left(t\right)-{\varepsilon }_0\right)}^{-1}\mathrm{or}\text{:}& \mathrm{Eqn}.\left(12\right)\\ {\left[\begin{array}{ccc}{F}_x& 0& 0\\ 0& F_y& 0\\ 0& 0& F_z\end{array}\right]\left[\begin{array}{ccc}\left({\varepsilon }_1-{\varepsilon }_1^0\right)& \left({\varepsilon }_1^{\prime }-{\varepsilon }_1^0\right)& \left({\varepsilon }_1^{″}-{\varepsilon }_1^0\right)\\ \left({\varepsilon }_2-{\mathrm{<figure-callout\; label="\varepsilon "\; filenames="US20080294144A1-20081127-D00001.png"\; state="\{\{state\}\}">\varepsilon </figure-callout>}}_2^0\right)& \left({\mathrm{<figure-callout\; label="\varepsilon "\; filenames="US20080294144A1-20081127-D00001.png"\; state="\{\{state\}\}">\varepsilon </figure-callout>}}_2^{\prime }-{\mathrm{<figure-callout\; label="\varepsilon "\; filenames="US20080294144A1-20081127-D00001.png"\; state="\{\{state\}\}">\varepsilon </figure-callout>}}_2^0\right)& \left({\mathrm{<figure-callout\; label="\varepsilon "\; filenames="US20080294144A1-20081127-D00001.png"\; state="\{\{state\}\}">\varepsilon </figure-callout>}}_2^{″}-{\mathrm{<figure-callout\; label="\varepsilon "\; filenames="US20080294144A1-20081127-D00001.png"\; state="\{\{state\}\}">\varepsilon </figure-callout>}}_2^0\right)\\ \left({\varepsilon }_3-{\varepsilon }_3^0\right)& \left({\varepsilon }_3^{\prime }-{\varepsilon }_3^0\right)& \left({\varepsilon }_3^{″}-{\varepsilon }_3^0\right)\end{array}\right]}^{-1}=\left[\begin{array}{c}{k}_{11}k_{12}k_{13}\\ k_{21}{\mathrm{<figure-callout\; label="k"\; filenames="US20080294144A1-20081127-D00001.png,US20080294144A1-20081127-D00003.png"\; state="\{\{state\}\}">k</figure-callout>}}_{22}k_{23}\\ k_{31}{\mathrm{<figure-callout\; label="k"\; filenames="US20080294144A1-20081127-D00001.png,US20080294144A1-20081127-D00003.png"\; state="\{\{state\}\}">k</figure-callout>}}_{32}k_{33}\end{array}\right]& \mathrm{Eqn}.\left(13\right)\end{array}$
• Force-to-strain conversion matrix K then may be stored instorage device79 associated with the corresponding deformable body, as disclosed herein. The values of the force-to-conversion matrix then may be input to console77 when the deformable body is coupled to the console using a bar code reader, input pad or direct electrical connection through transmitting/receivingline84. Once matrix K is provided for a given deformable body, the normal force, transverse force and angle of application of the transverse force may be computed as described above and using Table I.
• The values for the normal force, transverse force and angle of application of the transverse force, computed as described above, may be output as numerical values to a display monitor that forms part ofconsole77. In addition, a graphic including a variable size or colored arrow may be displayed pointing at a position on the circumference of a circle to visualize the magnitude and direction of the transverse force applied to the distal extremity of the deformable body. By monitoring this display, the operator may continuously obtain feedback concerning the contact forces applied to the distal extremity of the deformable body.
• The invention may be practiced in other embodiments not disclosed herein, such as endoscopic or additional intravascular applications. For example, various aspects of the disclosed embodiments may be utilized in a diagnostic catheter for optimizing or otherwise improving the placement of excitation electrodes for baroreflex activation. Other aspects of the disclosed embodiments may find application in endoscopic applications, such as orthoscopic surgery or entry through open orifices such as the throat, nose or anus without departing from the spirit of the invention.
• References to relative terms such as upper and lower, front and back, left and right, or the like, are intended for convenience of description and are not contemplated to limit the invention, or its components, to any specific orientation. All dimensions depicted in the figures may vary with a potential design and the intended use of a specific embodiment of this invention without departing from the scope thereof.
• Each of the additional figures and methods disclosed herein may be used separately, or in conjunction with other features and methods, to provide improved devices, systems and methods for making and using the same. Therefore, combinations of features and methods disclosed herein may not be necessary to practice the invention in its broadest sense and are instead disclosed merely to particularly describe representative embodiments of the invention.
• For purposes of interpreting the claims for the present invention, it is expressly intended that the provisions of Section 112, sixth paragraph of 35 U.S.C. are not to be invoked unless the specific terms “means for” or “step for” are recited in the subject claim.

Claims (41)

1. A catheter for use in a medical procedure comprising:

a flexible elongate body adopted to be introduced into a patient during said medical procedure and including a strain sensing assembly proximate a deformable portion of said elongate body, said strain sensing assembly including:

a proximal portion and a distal portion separated by at least one standoff member to define a separation between said proximal portion and said distal portion;

a plurality of transmitting elements extending from said proximal portion and partially spanning said separation, each of said plurality of transmitting elements including a free end to define a plurality of free ends located between said proximal portion and said distal portion; and

at least one reflecting element operatively coupled with at least one of said plurality of free ends to define a plurality of gaps for interferometery, one of said plurality of gaps being presented between each of said plurality of free ends and said at least one reflecting element, each of said plurality of gaps having an operative length between the respective free end and the at least one reflecting element, said operative length being variable and responsive to deformation of said deformable portion of said elongate body,

wherein said at least one standoff portion and said transmitting element include a substantially similar coefficient of thermal expansion in a direction parallel to said operative lengths of said plurality of gaps so that each of said operative lengths remains within a predetermined range when said deformable portion of said elongate body is subject to a predetermined range of bulk temperature change.

2. The catheter ofclaim 1 further comprising:

a source of electromagnetic radiation operatively coupled to each of said plurality of transmitting elements and transmitting electromagnetic radiation to each of said plurality of gaps to form a plurality of interferometers, each of said interferometers outputting a modulated waveform characteristic of the corresponding of said operative lengths;

a receiver operatively coupled to said plurality of transmitting elements to detect said modulated waveform; and

means operatively coupled to said receiver for analyzing said modulated waveform to infer at least one strain on said deformable portion of said elongate body.

3. The catheter ofclaim 2 further comprising means for resolving a force vector from said at least one strain, said force vector having at least one of an axial component and a transverse component.

4. The catheter ofclaim 1 wherein said at least one standoff member includes a plurality of standoff members, said plurality of standoff members equaling the number of said plurality of transmitting elements.

5. The catheter ofclaim 4 wherein at least one of said plurality of transmitting elements is coaxial with a corresponding one of said plurality of standoff members.

6. The catheter ofclaim 1 wherein said at least one standoff member is mounted to said proximal portion and said distal portion to define an active length that is at least 100 times greater than each of said operative lengths.

7. The catheter ofclaim 1 wherein said at least one reflecting element is disposed on a face of said distal portion.

8. The catheter ofclaim 1 wherein a difference of said substantially similar coefficients of thermal expansion of said standoff portion and said transmitting element is within 2 μ/K.

9. The catheter ofclaim 1 wherein said at least one reflecting element comprises a plurality of reflecting elements, one reflecting element corresponding to each of said plurality of transmitting elements, said plurality of reflecting elements and said plurality of transmitting elements having substantially equal coefficients of thermal expansion.

10. The catheter ofclaim 1 wherein said interferometer is a Fabry-Perot interferometer.

11. The catheter ofclaim 1 further comprising:

an radio frequency ablator head positioned proximate a distal portion of said elongate body and supported by said distal portion of said strain sensing assembly;

an irrigation tube in fluid communication with said radio frequency ablator head; and

means for thermally isolating said irrigation tube from said deformable portion of said elongate body.

12. The catheter ofclaim 11 wherein said means for thermally isolating said irrigation tube from said at least one standoff member includes structure defining a radial gap between said at least one standoff member and said irrigation tube.

13. The catheter ofclaim 11 further comprising a bellows structure that accommodates differential thermal expansion between said irrigation tube and said deformable structure.

14. The catheter ofclaim 1 wherein said at least one standoff member, said proximal portion and said distal portion comprise the same material.

15. The catheter ofclaim 14 wherein said at least one standoff member, said proximal portion and said distal portion are a unibody structure.

16. The catheter ofclaim 15 wherein said at least one standoff member is a stem that defines a central axis and having a first radius, said plurality of transmitting elements being substantially parallel to and at a second radius from said central axis, said second radius being greater than said first radius.

17. The catheter ofclaim 16 further comprising a closure around said transmitting elements, said closure including a thin membrane.

18. A configuration for mechanically amplifying the displacement of a fiber optic strain gage comprising:

a standoff member attached to a deformable structure at two locations with a span length between said locations;

an optical transmitting element extending substantially parallel to said standoff member along said span length, said optical transmitting element being attached to said standoff member and including a free end that is partially reflective, said optical transmitting element having a coefficient of thermal expansion substantially similar to said optical transmitting element; and

a reflector facing said free end to define an interferometric gap therebetween, said interferometric gap having an operative length,

wherein said operative length of said interferometric gap is varied when said standoff member is subjected to a mechanical strain for operation of said interferometric gap as said fiber optic strain gauge.

19. The configuration ofclaim 18 wherein said interferometric gap is a Fabry-Perot resonator.

20. The configuration ofclaim 18 wherein said standoff member and said transmitting element are coaxial.

21. A method of making a strain sensor assembly comprising:

selecting at least one transmitting element having a first coefficient of thermal expansion;

fabricating a deformable structure including at least one standoff member, each of said at least one standoff member having a second coefficient of thermal expansion that is substantially similar to said first coefficient of thermal expansion; and

attaching said transmitting element to said deformable structure to provide an active length of said strain sensor assembly.

22. A strain sensor assembly comprising

a deformable structure;

a plurality of gap interferometers operably coupled with said deformable structure, each of said plurality of gap interferometers including a transmitting element and having an operative length that varies when said deformable structure is subjected to an external force, said transmitting element and said deformable structure having materials with similar coefficients of thermal expansion that enables said operative length to remain within a predetermined range when said deformable structure is subject to a predetermined range of bulk temperature change.

23. The strain sensor assembly ofclaim 22 wherein said deformable structure includes a base portion, a distal portion and a stem portion.

24. The strain sensor assembly ofclaim 23 wherein said deformable structure is a unibody.

25. A strain sensor assembly comprising:

a plurality of transmitting elements operatively coupled with at least one reflecting element to define a plurality of interferometric gaps, each of said interferometric gaps being characterized by an operative length;

means for mechanically amplifying a change in said operative lengths when said strain sensor assembly is subjected to an external force; and

means for maintaining said operative lengths within a predetermined range when said strain sensor assembly is subject to a predetermined range of bulk temperature change.

26. The strain sensor assembly ofclaim 25 further comprising

an end effector operatively coupled with said strain sensor assembly, said end effector presenting a temperature extreme of said strain sensor assembly;

means for limiting differential thermal expansion within said strain sensor assembly; and

means for thermally isolating said strain sensor assembly from said temperature extreme of said strain sensor assembly.

27. The strain sensor assembly ofclaim 26 further comprising

an appurtenance operatively coupled with said end effector, said appurtenance presenting a second temperature extreme of said strain sensor assembly; and

means for thermally isolating said strain sensor assembly from said second temperature extreme of said strain sensor assembly.

28. A method of making a strain sensor assembly comprising:

selecting a strain sensing element including a transmitting element coaxial with a standoff member, said transmitting element and said standoff member having a substantially similar first coefficient of thermal expansion;

fabricating a deformable structure having a second coefficient of thermal expansion that is substantially similar to said first coefficient of thermal expansion; and

attaching said strain sensing element to said deformable structure to provide an active length.

29. The method ofclaim 28 wherein said attaching said strain sensing element includes:

applying a solvent to a region of said deformable structure that causes at least a portion of said region to melt;

placing said strain sensing element in contact with said region; and

removing said solvent from said deformable structure.

30. A force sensing catheter assembly comprising:

a deformable structure having a first coefficient of thermal expansion; and

a plurality of strain sensing elements operatively coupled with said deformable structure, each of said plurality of strain sensing elements including a transmitting element and a reflecting element coaxial with and attached to a standoff member to form a gap having an operative length between said transmitting element and said reflecting element, said transmitting element, said reflecting element and said standoff member each having a coefficient of thermal expansion substantially similar to said first coefficient of thermal expansion.

31. The force sensing catheter ofclaim 30 further comprising:

a source of electromagnetic radiation operatively coupled to each of said plurality of strain sensing elements and transmitting electromagnetic radiation to each of said plurality strain sensing elements to affect a plurality of Fabry-Perot interferometers that each output a modulated waveform characteristic of the corresponding one of said operative lengths; and

a receiver operatively coupled to said plurality of strain sensing elements to detect said modulated waveform;

means operatively coupled to said receiver for analyzing said modulated waveform to infer at least one strain on said deformable structure.

32. The force sensing catheter ofclaim 30 further comprising:

a radio frequency ablator head operatively supported by said deformable structure;

an irrigation tube in fluid communication with said radio frequency ablator head; and

means for thermally isolating said irrigation tube from said deformable structure.

33. The force sensing catheter ofclaim 32 wherein said means for thermally isolating said irrigation tube from said deformable structure includes structuring defining a radial gap between said deformable structure and said irrigation tube.

34. A device for introduction into a human or animal body comprising:

a flexible elongate body adapted to traverse a body passageway, the elongate body having a distal extremity for contact with a tissue wall of a vessel or organ;

a deformable body operatively coupled with said flexible elongate body that deforms in response to a contact force generated between said distal extremity and said tissue wall of said vessel or organ, said deformable body having a first coefficient of thermal expansion;

a plurality of optical fiber sensors, each responsive to said contact force, said plurality of optical fiber sensors having a second coefficient of thermal expansion substantially similar to said first coefficient of thermal expansion such that an indication of said contact force is generated by each of said optical fiber sensors when sourced with electromagnetic radiation, said indication being relatively insensitive to temperature over an operating range of temperatures of at least 5° C.

35. The device ofclaim 34 wherein said first coefficient of thermal expansion is within 2 μ/K of said second coefficient of thermal expansion.

36. The device ofclaim 34 wherein said fiber optical sensors include Fabry-Perot resonators.

37. The device ofclaim 34 further comprising:

a source of electromagnetic radiation operatively coupled to each of said plurality of fiber optic sensors to provide said indication of said contact force;

a receiver operatively coupled to said plurality of fiber optic sensors to detect said indication of said contact force;

means operatively coupled to said receiver for analyzing said indication of said contact force to infer at least one component of force on said deformable body.

38. The device ofclaim 34 further comprising:

a radio frequency ablator head operatively supported by said flexible elongate body proximate said distal extremity;

an irrigation tube in fluid communication with said radio frequency ablator head; and

means for thermally isolating said irrigation tube from said deformable structure.

39. A device for use in a medical procedure comprising:

an elongate catheter including a proximal portion, a middle portion and a distal portion, said distal portion including an end effector and being deflectable relative to said middle portion, said elongate catheter adopted to be introduced into an internal structure of a patient during said medical procedure, said internal structure having an interior wall; and

a force sensing assembly having at least a portion operatively coupled to said distal portion to detect a force exerted on said end effector, said force causing a deflection of said distal portion relative to said middle portion, said force being in reaction to said end effector being placed in contact with said interior wall of said internal structure.

40. The device ofclaim 39 wherein said force sensing assembly is arranged to resolve said force in at least two components.

41. The device ofclaim 39 wherein said force sensing assembly includes a fiber optic strain gauge.

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